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Based on interview, clinical record review, and policy review, the facility failed to ensure physician's orders specified which type of physical restraint to use for 2 patients (#s 24 and 25). Failure to ensure the orders specified a physical restraint intervention placed the patients at risk for a more restrictive restraint method. Findings:


Patient #24


Review of the clinical record on 8/23-24/12 revealed the Patient was admitted to the mental health unit (MHU) of the hospital from 3/9/12 until 4/9/12. The Patient's diagnoses included schizophrenia (a mental disorder that can cause hallucinations and delusions).


Review of the "Violent (Behavioral) Restraints/Seclusion Order", dated 3/10/12, revealed the Patient was being a danger to himself and others. Further review of the document revealed "Restraint" and "Seclusion" were to be used. The order did not specify what type of restraint to use.


During an interview on 8/23/12 at 10:45 am, when asked how the staff knew what type of restraint to use, the MHU Manager replied nursing staff would determine which restraint type was the least restrictive.


Review of the "Seclusion/ Restraint Flowsheet", dated 3/10/12, revealed the Patient was placed in five-point leather restraints (leather cuffs that restrain both arms and legs, and a leather belt around the waist) for almost 2 hours.


Review of the facility's policy "Restraint/Seclusion Management", revised 6/21/12, revealed that "Restraint Orders" for "Violent (Behavioral) Restraint/Seclusion" must include the "Type of restraint".


Patient #25


Review of the clinical record on 8/23-24/12 revealed Patient #25 was admitted to the MHU of the hospital on 7/3/12 with diagnoses that included bipolar disorder with a psychotic break (mood swings with manic episodes and a delusional break with reality).


Review of the physician's orders, dated 7/17/12, revealed "Patient has been adjudicated incompetent to give informed consent...Pts [Patient's] Durable Power of Attorney for health care has given me verbal consent for IV [intravenous] fluids as previously ordered, including use of restraints if necessary to accomplish such."


Review of the "Altered Mental Status Flowsheet (Restraint Orders for Medical Restraints)", dated 7/17/12, revealed the physician had not indicated what type of restraint to use. In addition, the order was not signed by the physician.


Review of the "Restraints/Seclusion Flowsheet", dated 7/17/12, revealed Patient #25 was in four-point leather restraints (leather cuffs that restrain the arms and legs) for over 2 hours while receiving IV fluids.


Review of the facility's policy "Restraint/Seclusion Management", revised 6/21/12, revealed that "Restraint Orders" for "Nonviolent (Medical) Restraints" must include the "Type of restraint that is to be used/required".


During an interview on 8/23/12 at 10:45 am, when asked about the missing information in the orders, the MHU Manager confirmed the physician's orders did not specify the restraint types to be used.


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Based on observation, interview, and record review the facility failed to ensure expired medication was not given to 1 patient (#14) of 6 sampled medical surgical patients for which medication reviews were completed. This placed the patient at risk for receiving expired medication that was potentially ineffective. Findings:

Medical record review on 8/21/12 for Patient # 14 revealed the Patient was admitted to the facility on 8/19/12 with a primary diagnosis of Hyperammonemia (a metabolic disturbance characterized by an excess of ammonia in the blood).

Observation on 8/21/12 at 11:35 am of the medical/surgical unit's medication cart revealed Patient #14's medication caddy had 2 bottles of Buphenyl, a medication that helps to remove ammonia from the body, with expiration dates of 11/05 and 10/08.

Review of the Medication Administration Record for Patient #14 revealed the expired medication had been given to the Patient 6 times since admission on 8/19/12.

During an interview on 8/21/12 at 11:40 am, RN #1 confirmed the Patient was being given the expired medication. When the Surveyor asked why, the RN said the medication was really expensive and the Patient would not pay for new medication so the Pharmacist and the Patient's doctor decided to go ahead and give her the expired medication.

During an interview on 3/22/12 at 1 pm, Pharmacy Staff #1 confirmed the expired Buphenyl was being given to the Patient. Staff #1 said the Patient would not take a medication substitute or allow the hospital to order new Buphenyl because the cost of the medication was $2,000 per bottle. The Surveyor asked if the Pharmacy had contacted the manufacturer of the medication to see if it was safe for the Patient to take medication that was 5-7 years past the expiration dates. Staff #1 said that would have probably been a good idea, but they had not made any contact with the manufacturer.

Review of the facility's policy and procedure "Patients Own Medications", last revised on 5/12, revealed the Pharmacy was to "Determine if possible, that the medication is in date..." The policy did not address how the Pharmacy staff was to proceed if the medication was expired.


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Based on observation, interview, and record review the facility failed to ensure expired medications and opened, undated, multidose vials of medications were removed from stock. This placed patients at risk for receiving outdated, potentially ineffective medications. Findings:



Observations in the obstetrics surgical suite on 8/21/12 at 4:00 pm revealed an anesthesiology medication cart. The top drawer contained a 250 ml bottle of Nitroglycerine (a medication that increases blood flow by dilating blood vessel walls) in 5% dextrose, with an expiration date of April, 2012. The third drawer of the cart contained 3 opened multidose vials of Sodium Bicarbonate; there was nothing written on the vials that indicated the dates they were opened.



During an interview on 8/21/12 at 4:40 pm, when asked about the oversight of medications in the anesthesia cart, the Regulatory Specialist and Registered Nurse #3 both replied that the anesthesiologist had control of the cart and added that the pharmacy checked the anesthesia carts monthly for expired medications.


Further observations in the obstetrics surgical suite revealed an anesthesiology machine. The top drawer of the anesthesiology machine contained 3 cans of Sevoflurane (anesthetic gas) with an expiration date of 6/2012. One of the cans had been opened and was partially used.


During an interview on 8/23/12 at 3:20 pm, when asked about the expired medications, Anesthesiologist #1 replied he was surprised the Sevoflurane was expired because "we use that all the time." When asked about the process for checking the cart for outdates and restocking the medications, the Anesthesiologist replied the pharmacy came over to do that.


Review of the "Stores Requisition" and the "Medication Area Inspection Log", provided by the facility as documentation of the pharmacy's inspection of the anesthesia medication carts, revealed incomplete documentation. Further review of the documents revealed the most recent medication area inspection for an anesthesia cart was dated 1/10/12, over 7 months ago.


Review of the facility's policy "Anesthesia Medication Storage in Carts", review date 7/2/08, revealed "All carts will be inspected on a monthly basis by the pharmacy technicians. All out of date medications, medications that will outdate in the next month, or any medication with an unknown beyond use date will be removed and restocked by the technicians during the inspection" and "Any undated MDV [Multidose vial] will be discarded as expired."